Hologic HPV Genotype Assay Receives FDA Approval

FDA approved Hologic's APTIMA HPV 16 18/45 Genotype Assay designed for the company's TIGRIS instrument system. This assay provides follow-up testing for women with positive results from the APTIMA HPV Assay. Using Hologic’s ThinPrep liquid cytology specimens, the APTIMA HPV 16 18/45 Assay identifies human papillomavirus (HPV) types 16, 18, and 45, which cause approximately 80% of all invasive cervical cancers worldwide. It is the first test of its kind to receive FDA approval. Hologic acquired the assay as part of the company's August 2012 purchase of Gen-Probe.

Sysmex Hematology Analyzers Get FDA Nod

FDA granted clearance to Sysmex's XN-Series Hematology Analyzers. This scalable series of instruments includes the XN-1000, XN-2000, XN-3000, and XN-9000. The instruments feature advanced clinical parameters, such as nucleated red blood cells with every complete blood count, immature granulocytes with every differential, RET-He within the reticulocyte profile, and a new fluorescent platelet channel for immature platelet fraction that facilitates the differential diagnosis of thrombocytopenia. The XN-9000 also provides labs with automated sample tube sorting and archiving capabilities.

FDA Clears Roche POC Blood Glucose Monitor

Roche received clearance for its point-of-care blood glucose monitor, the ACCU-CHEK Inform II system. The device's meter and test strip provide test results in 5 seconds using a 0.6-µL capillary blood sample, while its design eliminates interference from maltose, xylose, and oxygen. Proprietary technology also allows for automatic real-time wireless transfer of patient data between hospital medical staff and the lab, making the ACCU-CHEK Inform II system the first wireless hospital blood glucose monitor.

FDA Deems Bloodstream Infection Test Moderate Complexity

FDA gave a CLIA moderate-complexity rating to Nanosphere's Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the Verigene System. The test detects a wide range of clinically significant Gram-positive bacteria at the genus and species level and identifies bacteria that are resistant to methicillin/oxacillin and vancomycin by detecting the mecA, vanA, and vanB genes. Results are available in as few as 2.5 hours, unlike current microbiological culture techniques that take 24–48 hours to identify bacterial pathogens and their antibiotic resistance/susceptibility. The BC-GP test joins Nanosphere's Respiratory Virus Plus Nucleic Acid Test as the second infectious diseases assay on the Verigene System to gain CLIA moderate-complexity status.